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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000011400
Receipt No. R000013348
Scientific Title Establishment of a novel preoperative brain mapping system by navigated transcranial magnetic stimulation (nTMS)
Date of disclosure of the study information 2013/08/08
Last modified on 2014/01/26

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Basic information
Public title Establishment of a novel preoperative brain mapping system
by navigated transcranial magnetic stimulation (nTMS)
Acronym Establishment of a novel preoperative brain mapping system
by navigated transcranial magnetic stimulation (nTMS)
Scientific Title Establishment of a novel preoperative brain mapping system
by navigated transcranial magnetic stimulation (nTMS)
Scientific Title:Acronym Establishment of a novel preoperative brain mapping system
by navigated transcranial magnetic stimulation (nTMS)
Region
Japan

Condition
Condition brain tumor
Classification by specialty
Neurosurgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to evaluate the safety and effectiveness of preoperative nTMS before awake surgery for the identification of areas of language, motor and cognitive function in patients with brain tumors. Moreover, we aimed to establish a novel preoperative brain mapping system by nTMS by comparing the results from nTMS with direct cortical stimulation during awake cranitomy.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Any disturbance of speech, movement and cognitive function processing
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 Navigated transcranial magnetic stimulation
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
70 years-old >=
Gender Male and Female
Key inclusion criteria 1) Aged 20 to 70 years old
2) The patients who are planned to take a surgery for brain tumors that are associated with areas of language, motor and cognitive function
Key exclusion criteria 1) No cognitive disorders, aphasia, psychiatric disorders, higher brain dysfunctions
2) Those having heart pacemaker or drug infusion pomp
3) Those having severe heart diseases
4) Those having the deep brain stimulation or the spinal cord stimulation
5) Pregnant or intend to be pregnant
6) the patients who are excluded by doctors
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuya MOTOMURA
Organization Nagoya University Graduate School of Medicine
Division name Department of Neurosurgery
Zip code
Address 65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan
TEL 052-744-2353
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kazuya MOTOMURA
Organization Nagoya University Graduate School of Medicine
Division name Department of Neurosurgery
Zip code
Address 65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan
TEL 052-744-2353
Homepage URL
Email kmotomura@med.nagoya-u.ac.jp

Sponsor
Institute Department of Neurosurgery, Nagoya University Graduate School of Medicine
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2013 Year 08 Month 08 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2013 Year 07 Month 24 Day
Date of IRB
Anticipated trial start date
2013 Year 07 Month 24 Day
Last follow-up date
2018 Year 07 Month 23 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 08 Month 07 Day
Last modified on
2014 Year 01 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013348

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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